Phase 2
N=90
A Comparison of Fluoxetine and Divalproex for the Treatment of Intermittent Explosive Disorder
Intermittent Explosive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00078754 ↗Enrolled (actual)
90
Serious AEs
1.1%
Results posted
Dec 2014
Primary outcome: Primary: Overt Aggression Scale-Modified for Outpatient Use (OAS-M) — 7.86; 15.73; 8.88 units on a scale — p=0.622
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fluoxetine (Drug); Divalproex (Drug); Placebo (Drug)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of Chicago
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overt Aggression Scale-Modified for Outpatient Use (OAS-M) |
7.86; 15.73; 8.88 | 0.622 |
| SECONDARY OAS-M |
13.2; 13.7; 19.5; 25.1; 29.6; 26.9 | 0.029 sig |
Summary
This study will compare the medications fluoxetine (Prozac®) and divalproex (Depakote®) for the treatment of aggressive behavior in individuals with Intermittent Explosive Disorder (IED).
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Intermittent Explosive Disorder (IED)
- In good physical health
- Overt Aggression Scale-Modified (OAS-M) score of 15 or higher at screening
- Willing and able to comply with the study requirements
Exclusion Criteria
- Life history of bipolar disorder, schizophrenia, organic mental syndrome, or mental retardation
- Current major depressive disorder, with a Hamilton Depression (HAM-D) Scale score higher than 18
- Current alcohol or drug abuse or dependence
- Active medical conditions that will interfere with the study
- Thymoleptic or neuroleptic treatments
- Presence of the following serious and active medical conditions: demyelinating or progressive degenerative disorders; central nervous system infection; progressive degenerative neurological disorder; ischemic heart disease; respiratory, renal, or liver disease; Type I diabetes; malignant neoplasm; hyper- or hypo-coagulopathy; Acquired Immune Deficiency Syndrome (AIDS); or seizure disorder. Participants with a history of more than two febrile seizures prior to 1 year of age are eligible.
- Chronic, ongoing treatment with the following classes of medications: antidepressants, neuroleptics, mood stabilizers, antianxiety agents, hypnotics, narcotics or synthetic narcotics, barbiturates, stimulants, anti-migraine agents, anti-epileptics, non-beta-blocking or Ca-channel blocking anti-arrhythmic agents prescribed to treat cardiac arrhythmia, anticoagulants, immunomodulators, anti-neoplastic agents, or HIV antiviral agents
- Ongoing psychotherapeutic treatment for the treatment of IED or anger that was started less than 3 months before study entry
- Hypersensitivity to fluoxetine or divalproex
- Pregnancy
Data sourced from ClinicalTrials.gov (NCT00078754). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.